OIC Intramedullary Nail System GW03-1000-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10811998036851), received between Oct 21, 2020 and Oct 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2020Physical Resistance/Sticking

  THE OR TECHNICIAN WAS PREPARING INSTRUMENTS FOR A CASE. DURING A PRE-RUN OF ONE OF THE DEVICES TO MAKE SURE IT WOULD WORK PROPERLY BEFORE STARTING THE CASE, A GUIDE ROD GOT STUCK IN AN OIC HANDLE. AFTER MANY ATTEMPTS BY THE OR TECH AND SURGEON, IT WAS DETERMINED THAT THE GUIDE ROD WAS MALFUNCTIONING. A NEW GUIDE ROD AND OIC IM NAIL BASE SET WERE OPENED AND EVERYTHING WENT FINE AFTERWARD. DEVICE INFORMATION: GUIDE ROD IS OIC 3.0MM X 1000MM BALL TIP GUIDE ROD. STERILE PART # GW03-1000-S. LOT # 19-02005. THE HANDLE CAME FROM THE OIC IM NAIL BASE SET (YELLOW T-SHAPED HANDLE).

  Patient problems: Insufficient Information

  MAUDE report 10710994 ↗